PRITAM INTERNATIONAL PRIVATE LIMITED – FDA 483, Jun 2, 2026

Pritam International Pvt. Ltd. in Roorkee, India, an OTC drug manufacturer, was cited for significant deficiencies during an FDA inspection. The observations highlight critical issues across laboratory controls, process validation, batch recordkeeping, equipment cleaning, and quality system oversight. These deficiencies indicate a lack of robust controls to ensure the quality, safety, and purity of their drug products.